Innovation Series 2005
Idealized Design
of Perinatal Care
The Institute for Healthcare Improvement thanks Ascension Health and
Premier, Inc., our colleagues in this important work to improve the safety
and effectiveness of perinatal care.
9
We have developed IHI’s Innovation Series white papers to further our mission of improving the
quality and value of health care. The ideas and findings in these white papers represent innovative
work by organizations affiliated with IHI. Our white papers are designed to share with readers the
problems IHI is working to address; the ideas, changes, and methods we are developing and testing
to help organizations make breakthrough improvements; and early results where they exist.
Copyright © 2005 Institute for Healthcare Improvement
All rights reserved. Individuals may photocopy all or parts of white papers for educational, not-for­
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means (electronic, mechanical, xerographic, or other), or held in any information storage or retrieval
system without the written permission of the Institute for Healthcare Improvement.
How to cite this paper:
Cherouny PH, Federico FA, Haraden C, Leavitt Gullo S, Resar R. Idealized Design of Perinatal Care.
IHI Innovation Series white paper. Cambridge, Massachusetts: Institute for Healthcare Improvement;
2005. (Available on www.IHI.org)
Acknowledgements:
Thanks are due to many Institute for Healthcare Improvement (IHI) faculty and staff for their advice
and critical review of this paper, particularly Don Goldmann, MD, Senior Vice President, IHI, and
Professor of Pediatrics, Harvard Medical School; Frank Davidoff, MD; Jane Roessner, PhD; and Val Weber.
For reprint requests, please contact:
Institute for Healthcare Improvement, 20 University Road, 7th Floor, Cambridge, MA 02138
Telephone (617) 301-4800, or visit our website at www.ihi.org
Innovation Series 2005
Idealized Design
of Perinatal Care
Authors:
Peter H. Cherouny, MD: Professor of Obstetrics and Gynecology, University of Vermont College of Medicine
Frank A. Federico, RPh: Director, Institute for Healthcare Improvement
Carol Haraden, PhD: Vice President, Institute for Healthcare Improvement
Sue Leavitt Gullo, MS, RN: Director, Institute for Healthcare Improvement
Roger Resar, MD: Senior Fellow, Institute for Healthcare Improvement, Luther Midelfort-Mayo Health System
Editor: Faith McLellan, PhD
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Innovation Series: Idealized Design of Perinatal Care
Thank you to our colleagues in this important work:
Premier Healthcare Informatics and Insurance Management Services staff have provided invaluable
leadership throughout the Idealized Design of Perinatal Care project. Premier’s mission, to improve
the health of communities, drove its involvement in the project. Through its clinical databases and
risk management offerings, Premier’s focus on improving health care quality and outcomes is well
aligned with IHI. Premier thanks the ten Premier owner organizations that served as the participants
in Phase I and the additional five Premier owners that joined the project in Phase II. Together, IHI
and Premier are advancing the imperative for quality improvement.
Ascension Health (www.ascensionhealth.org) is the nation’s largest Catholic and nonprofit health
system, with more than 105,000 associates serving in 20 states and the District of Columbia.
Consistent with its mission to serve all people with special attention to those who are poor and
vulnerable, Ascension Health is an innovative leader in transforming health care through patientcentered, holistic care of the highest clinical quality. Ascension Health’s Alpha Ministries have
been involved in transforming care in perinatal safety for almost two years as part of the Clinical
Excellence goal of no preventable deaths or injuries by 2008. The Perinatal Safety Alpha Ministries
added the IHI innovation work in this area as part of a broad approach to develop high-reliability
units and claims prevention strategies. With five new teams now participating in the IHI innovation
project, Idealized Design of Perinatal Care, Ascension Health is pleased to continue to support
important endeavors such as this.
The Institute for Healthcare Improvement also acknowledges the contributions made by Kaiser
Permanente in the field of perinatal safety, especially in the areas of teamwork and communication
training, including the SBAR technique, some of which is incorporated in the Idealized Design of
Perinatal Care project.
© 2005 Institute for Healthcare Improvement
Institute for Healthcare Improvement Cambridge, Massachusetts
Executive Summary
Idealized Design of Perinatal Care is an innovation project based on the principles of reliability
science and the Institute for Healthcare Improvement’s (IHI’s) model for applying these principles
to improve care.1 The project builds upon similar processes developed for other clinical arenas in
three previous IHI Idealized Design projects. The Idealized Design model focuses on comprehensive
redesign to enable a care system to perform substantially better in the future than the best it can do
at present. The goal of Idealized Design of Perinatal Care is to achieve a new level of safer, more
effective care and to minimize some of the risks identified in medical malpractice cases.
The model described in this white paper, Idealized Design of Perinatal Care, represents the Institute
for Healthcare Improvement’s best current assessment of the components of the safest and most
reliable system of perinatal care. The four key components of the model are: 1) the development of
reliable clinical processes to manage labor and delivery; 2) the use of principles that improve safety
(i.e., preventing, detecting, and mitigating errors); 3) the establishment of prepared and activated
care teams that communicate effectively with each other and with mothers and families; and 4) a
focus on mother and family as the locus of control during labor and delivery.
Reviews of perinatal care have consistently pointed to failures of communication among the care team
and documentation of care as common factors in adverse events that occur in labor and delivery. They
are also prime factors leading to malpractice claims.2
Two perinatal care “bundles”— a group of evidence-based interventions related to a disease or care
process that, when executed together, result in better outcomes than when implemented individually
— are being tested in this Idealized Design project: the Elective Induction Bundle and the Augmentation
Bundle. Experience from the use of bundles in other clinical areas, such as care of the ventilated
patient, has shown that reliably applying these evidence-based interventions can dramatically
improve outcomes.3 The assumption of this innovation work is that the use of bundles in the
delivery of perinatal care will have a similar effect.
The authors acknowledge that other organizations have also been working on improving perinatal
care through the use of simulation training and teamwork and communication training. IHI’s
model includes elements of these methods.
The Idealized Design of Perinatal Care project has two phases. Sixteen perinatal units from hospitals
around the US participated in Phase I, from February to August 2005. The goals of Phase I were
identifying changes that would make the most impact on improving perinatal care, selecting elements
for each of the bundles, learning how to apply IHI’s reliability model to improve processes, and
improving the culture within a perinatal unit. This white paper provides detail about the Idealized
Design process and examines some of the initial work completed by teams.
© 2005 Institute for Healthcare Improvement
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Innovation Series: Idealized Design of Perinatal Care
Phase II, which began in September 2005, expands on this work. This phase focuses particularly on
managing second stage labor, including common interpretation of fetal heart monitoring, developing
a reliable tool to identify harm, and ensuring that patient preferences are known and honored.
Introduction
Adverse events occurring during labor and delivery are rare relative to the number of births, but
when they do occur they can result in significant harm. The effects of an adverse event—physical,
psychological, and financial— take a heavy toll on the child, the family, and the clinicians involved.
Families may be left to care for a child who has enormous needs, and their only recourse for obtaining
financial assistance to meet these needs may be to pursue legal action.
Malpractice claims in obstetrics and gynecology are not uncommon. According to the American
College of Obstetricians and Gynecologists (ACOG), obstetricians and gynecologists have an average
of 2.6 claims filed against them during their career. Of these, 61 percent are obstetrics-related cases.4
Claims related to a brain-damaged infant were among the top five conditions for which compensation
was sought during the period from 1985 to 2003, with an average indemnity of $509,280.5
According to the 2003 National Practitioner Data Bank report, obstetrics-related cases (totaling
1,255) generated 8.1 percent of all physician malpractice payment reports, had the highest median
($290,000) and mean ($475,880) payment amounts, and took the longest amount of time to resolve
compared with anesthesia-related cases (the mean delay between incident and payment in obstetrics
was 5.66 years, median 4.74 years; compared with 3.67 and 3.30 years, respectively, in anesthesia).
The median malpractice award for a childbirth-related claim involving obstetricians and hospitals was
$2.5 million for the period from 1997 to 2003.6 In part because of these statistics, liability insurance
premiums for obstetricians and hospitals with large OB services have risen dramatically.
The best defense against malpractice claims— and indeed for providing the best care for patients—
is prevention or minimization of harm whenever possible, through adherence to evidence-based
practice guidelines. Professional organizations such as ACOG and the Association of Women’s
Health, Obstetric and Neonatal Nurses (AWHONN) have developed a number of practice guidelines
and position statements (Figure 1). The challenge is ensuring that these guidelines are used consistently.
Guidelines also evolve, based on new research, and must be revisited periodically by clinicians to
determine their impact on local practice. Further, the Idealized Design project recognizes that
evidence-based care must be provided by a care team that works together smoothly and effectively
(a high-functioning team, as described below), complemented by complete and accurate documentation
of that care.7
© 2005 Institute for Healthcare Improvement
Institute for Healthcare Improvement Cambridge, Massachusetts
Figure 1. Examples of Position Statements and Bulletins Related to the Idealized Design of Perinatal Care
AWHONN Clinical Position Statements
• Fetal Assessment, Revised and Reaffirmed, April 2000
• Professional Nursing Support of Laboring Women, Approved by the Executive Board, April 2000
ACOG Practice Bulletins
• Induction of Labor, ACOG Practice Bulletin, Number 10, November 1999
• Intrapartum Fetal Heart Rate Monitoring, ACOG Practice Bulletin, Number 70, December 2005
Additional ACOG References
• ACOG Committee Opinion, Patient Safety in Obstetrics and Gynecology, Number 286,
October 2003
• ACOG Practice Bulletin, Fetal Macrosomia, Number 22, November 2000
• ACOG Practice Bulletin, Shoulder Dystocia, Number 40, November 2002
• ACOG Practice Bulletin, Dystocia and the Augmentation of Labor, Number 49, December 2003
Poor documentation of care not only impedes communication among providers, but often complicates
defense against malpractice claims. Incomplete or absent documentation may be interpreted as
indicating a lack of planning for a particular course of action, and gaps in documentation make it
difficult to determine the rationale behind a decision. Another potential problem with documentation
can occur when the medical record contains contradictory statements, due to differences in
interpretation, recorded by different providers. The wide variation in the way obstetricians and
nurses interpret the fetal monitoring strip may be due to the absence of a common language for
interpretation, lack of multidisciplinary training in teamwork and communication, and variability
in processes of care.
Reviews of perinatal care (from individual cases and claims analysis) show that poor communication
among providers and with patients contributes to care that is less than optimal and may increase the
risk of a malpractice claim. In one study of closed claims in obstetrics and gynecology, more than
one-third of adverse events were associated with communication problems ranging from basic mis­
communication among providers, to misunderstanding because of a lack of common terminology,
to delays in communication, and to a total absence of communication.8
The clinical processes in the Idealized Design project are designed to decrease the incidence of
communication problems. The two perinatal care bundles are based on reliability science and
provide a common language for team members, in order to improve teamwork and communication.
© 2005 Institute for Healthcare Improvement
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Innovation Series: Idealized Design of Perinatal Care
The Idealized Design of Perinatal Care Model
Idealized Design of Perinatal Care is the fourth Idealized Design model developed by IHI. (The
first three models are Idealized Design of Clinical Office Practices,9 Idealized Design of Medication
Systems, and Idealized Design of the Intensive Care Unit.) Each of these designs has resulted in
improved outcomes in their respective clinical arenas.10 The goal of Idealized Design is to develop
the best possible “ideal” care system that its designers can conceive at that time. Furthermore,
Idealized Designs are capable of being improved and of improving themselves.11
Idealized Design of Perinatal Care is based on reliability science (failure-free operation over time),
including both what and how care is delivered. The what consists of the best science, the soundest
evidence, upon which to base practice. This evidence spans a wide spectrum, from the results of
randomized trials to expert opinion. The ACOG Practice Bulletins are examples of guidelines based
on peer-reviewed research.
The how is the method by which that evidence-based care is delivered (e.g., by using standardized
order sets). At present, the execution of best practices is highly variable, as demonstrated by chart
review and malpractice claims analysis. To improve safety and reliability, what we do and how we
do it must come together as the way we provide effective perinatal care.
The Model for Improvement12 is an effective methodology to test changes in processes that result in
the reliable delivery of the highest level of care. Delivering ideal care is based on reliable design and
a specific goal for each process that will make the greatest difference in care.
Simply improving current processes cannot achieve acceptable levels of reliability.13 Idealized Design
is based instead on a comprehensive redesign of the care system: determining what the best perinatal
care would look like, and how all the parts and players involved in its complex processes would
best fit together, in a “best possible world” scenario. Components include clinical processes,
communication and teamwork, and acknowledging and honoring the expressed preferences of
the mother and the family. Idealized Design of Perinatal Care is a method of marrying these factors
to produce a theory, an “educated best guess,” about the best perinatal care system.
© 2005 Institute for Healthcare Improvement
Institute for Healthcare Improvement Cambridge, Massachusetts
Figure 2. Idealized Design of Perinatal Care
Mother and Family as Source of Control
Productive
Conversations
Prepared and Activated Teams
RELIABLE PROCESSES
Prepared
& Activated
Mother
EVALUATE
ADMIT
PREVENT
FIRST
STAGE
LABOR
SECOND
STAGE
LABOR
IDENTIFY
BIRTH
Informed & Ready
Receiving Unit;
Stabilized Mother
and Baby
MITIGATE
APPROPRIATE INFRASTRUCTURE
Components of the Model
The Idealized Design of Perinatal Care model (Figure 2) consists of eight basic components:
• A prepared and activated mother and family;
• The mother and family as the source of control (patient preferences);
• Productive conversations between the mother, family, and the care team;
• High-functioning care teams (prepared and activated);
• Reliable processes used to evaluate and manage labor and delivery (the perinatal care “bundles”);
• Reliable processes to prevent, detect, and mitigate problems;
• An appropriate infrastructure that underlies the system of care; and
• A stabilized mother and baby, given into the care of an informed and ready patient care unit.
© 2005 Institute for Healthcare Improvement
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Innovation Series: Idealized Design of Perinatal Care
The mother and family as the source of control means the mother has the information she needs to
make informed decisions about her care, and is the source of control in the birth process. She, in
collaboration with the care team, is able to make good decisions about the selection and delivery
of her care. These shared goals create the conditions for delivering the safest and most reliable care.
Mothers and partners are provided with information in a way that takes into account health and
cultural literacy issues.
Productive conversations are defined as communications between the patient, her family, and the care
team that honor patient preferences and emphasize the safety of both mother and fetus, and are con­
tinually evaluated and updated during the birth process. For example, patients have opportunities to
list their preferences regarding delivery, pain management, and responses to their emotional needs.
A prepared and activated team that works together is a prerequisite for providing safe and reliable
care. Effective communication among team members is critical for the team to be highly functional.
SBAR (Situation-Background-Assessment-Recommendation)14 is an effective tool to help team
members communicate clearly and respectfully with each other in a focused and effective manner,
especially in urgent or critical situations. All relevant facts are communicated in a cogent, methodical
manner; concerns, recommendations, and requests are made specifically and clearly. Building on
the work in crew resource management, communication training includes education in appropriate
assertiveness and development of conflict resolution skills. Examples of applying these models can
be found in Kaiser Permanente’s work and in the Department of Defense/Agency for Healthcare
Research and Quality (AHRQ) teamwork training curricula. Effective oral communication then
translates into comprehensive written documentation that includes reasons for treatment decisions,
monitoring information, and indications of treatment plans.
Reliable processes are used to evaluate the mother and fetus, and to manage the labor and delivery process.
The Idealized Design of Perinatal Care bundles (described in more detail below) incorporate
processes that help create a culture of patient safety, and processes that clinicians believe are important
in contributing to good care for both the mother and the baby. By implementing the bundles and
measuring their effect, IHI anticipates being able to reduce harm in labor and delivery, as well as
being able to document that reduction.
These same reliable processes are also used to prevent, detect, and mitigate problems.15 Prevention
is, of course, preferable to anything else, but when problems cannot be prevented, providers must
be able to detect them and mitigate their effects quickly. In labor and delivery, for example, this
might mean collaborative interpretation of fetal monitoring based on common language and team
response.16 A common language is one in which descriptions of monitoring strips and desired
actions are the same for both obstetricians and nurses, without inconsistencies or ambiguities.
Once a problem is detected, action is taken based upon the results of detection. For example, the
interpretation of fetal monitoring might mean the mother needs to be repositioned to improve
© 2005 Institute for Healthcare Improvement
Institute for Healthcare Improvement Cambridge, Massachusetts
oxygenation to the fetus, thereby mitigating the problem detected. This cycle — prevent, detect,
mitigate — underpins the principles of safety in the Idealized Design.
An appropriate infrastructure in the perinatal unit is another prerequisite for providing safe and
reliable care. This infrastructure includes standard elements of multidisciplinary staff education
and preparation, ensuring staff competency, privileging, and adoption of common standards.
Finally, a stabilized mother and baby are given into the care of an informed and ready patient care unit.
Design Targets
To determine the effectiveness of the Idealized Design of Perinatal Care model, the expert faculty
established specific design targets — measurable raise-the-bar goals that indicate a dramatic
improvement in results for patients beyond the best known in health care today — that include
the following:
1.
Birth trauma (i.e., neonatal injury as defined in the AHRQ Patient Safety Indicators)17
is reduced to a maximum of 3.3 adverse events per 1,000 live births. According to AHRQ, the national estimate of birth trauma per 1,000 live births was 7.358 in 2001.18
2.
Patients (mothers) state that 95 percent of the time their wishes are known to the entire care
team and respected.
3.
Perinatal units report a 50 percent improvement in their culture survey scores. One example
of a culture survey tool is AHRQ’s Hospital Survey on Patient Safety Culture (HSOPSC).19
4.
All claims or allegations may be defended because they meet each institution’s internal
standards for defense (e.g., consistent documentation, no lapses in documentation, no lapses
in communication).
Implementation of the Perinatal Care Bundles
Idealized Design uses reliability principles to support the application of the “bundle” concept to
clinical processes.20 A bundle is a group of evidence-based interventions related to a disease or care
process that, when executed together, result in better outcomes than when implemented individually.
The selection of the evidence-based elements comprising the bundles is based on sound science and
local knowledge, and an agreement among clinicians that patients should receive all elements of care
unless medically contraindicated. Experience from the use of bundles in other clinical areas, such as
care of the ventilated patient, has shown that reliably applying these evidence-based interventions
can dramatically improve outcomes.21 The assumption of this innovation work is that the use of
bundles in the delivery of perinatal care will have a similar effect.
© 2005 Institute for Healthcare Improvement
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Bundles themselves do not improve outcomes, but the ability of the team to reliably implement
every element of the bundle for all patients, unless medically contraindicated, advances care in such
a way as to achieve the improved outcomes. The most important idea underlying bundles is the
“all or none” concept: A team gets credit for implementing the bundle only if every element of the
bundle is delivered for each patient, unless medically contraindicated. This goal serves as a catalyst
to move teams toward a design that achieves a 10-2 level of reliable performance (i.e., 95 percent of
the time patients receive all elements of the bundle).22 Providing care in the usual manner will not
accomplish this goal.
Implementation of the two bundles, the Elective Induction Bundle and the Augmentation Bundle,
is the focus of Phase I of the Idealized Design of Perinatal Care. Successful implementation requires
that teams comply with all components of the respective bundle for each patient, establishing
effective systems and a common language to ensure that obstetricians, nurses, and other caregivers
interpret the same clinical scenario in the same way.
Elective Induction Bundle
Review of medical malpractice claims reveals that oxytocin, which stimulates uterine contractions
and induces labor, is involved in more than 50 percent of the situations leading to birth trauma.
To minimize the opportunity for harm, it is necessary to understand the pharmacology of the drug
and its impact on the fetus, and to have protocols to guide its appropriate use. Based on findings
from reviews of adverse events, medical malpractice claims, and guidelines provided by professional
organizations, the expert faculty selected four elements that must be considered when using oxytocin
for labor induction:
• Assessment of gestational age (ensuring that gestational age is greater than or equal to 39 weeks);
• Monitoring fetal heart rate for reassurance;
• Pelvic assessment; and
• Monitoring and management of hyperstimulation.
Before the elective induction of labor is initiated, it must be determined that the fetus has a gestational
age of greater than or equal to 39 weeks, and this determination must be documented according
to agreed upon standards. Determining which care team member is responsible for establishing
gestational age and the method by which it is established are decisions that are left up to individual
sites. Although babies have been delivered before 39 weeks of gestational age, ACOG guidelines23
and other research report that the likelihood of harm to the baby from elective delivery is greater
before 39 weeks. In the event of an adverse outcome, plaintiffs’ attorneys may use non-compliance
with this guideline as an indicator of poor care.
© 2005 Institute for Healthcare Improvement
Institute for Healthcare Improvement Cambridge, Massachusetts
Likewise, monitoring fetal heart rate for reassurance before induction, in accordance with specific
definitions (detailed below), must be documented. Clinicians monitor fetal heart rate and the effects
of uterine stimulants on the fetus, and ensure the availability of a physician capable of performing
an emergency cesarean section, should it be necessary. For the first time, two major governing
organizations, ACOG and AWHONN, have accepted the definitions of fetal monitoring developed
by the National Institute for Child Health and Human Development (NICHD). This adoption is
based on the goal of using a standard terminology to describe fetal heart rate monitoring and then
developing an agreed upon plan of action to ensure compliance with this element of the bundle.
According to ACOG, “The presence of fetal heart rate accelerations generally ensures that the fetus
is not acidemic and provides reassurance of fetal status.” 24,25 Because the positive predictive value of
reassuring fetal assessment is high (>99 percent), it is vital that definitions are accepted and used by
all members of the care team.26
Pelvic examination to determine dilation, effacement, station, cervical position and consistency
(Bishop’s Score), and fetal presentation should be performed and documented. This confirms the
patient as a candidate for induction and allows a measure and evaluation of her progress in labor.
Again, pelvic assessment should be performed and documented by pelvic examination before the
induction is initiated.
Finally, because it is a frequent and potentially consequential occurrence during induced labor,
hyperstimulation must be identified using a standard definition and documented, and a plan for
a consensus response to the hyperstimulation must be made. The overall goal is to monitor for
hyperstimulation and respond appropriately. In this Idealized Design project, teams worked together
to develop a definition of hyperstimulation (generally agreed to be more than 5 contractions in
10 minutes), using information from the literature and guidelines from professional associations.27
Augmentation Bundle
Augmentation of labor is a coordinated effort to enhance uterine contractions for a woman who
is already in labor. One reason to augment labor is inadequate contractions in terms of strength
or frequency, resulting in inadequate progress of labor. Oxytocin is used to augment uterine
contractions. As with induction, four critical elements must be considered:
• Estimated fetal weight;
• Monitoring fetal heart rate for reassurance;
• Pelvic assessment; and
• Monitoring and management of hyperstimulation.
© 2005 Institute for Healthcare Improvement
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Innovation Series: Idealized Design of Perinatal Care
Estimation of fetal weight replaces gestational age in this bundle. It is important to know the size of
the fetus to determine whether a continued attempt at vaginal delivery is appropriate. Monitoring
for fetal reassurance and for uterine hyperstimulation and the teams’ responses to both have the same
implications as in the Elective Induction Bundle. Again, pelvic assessment should be performed and
documented by pelvic examination before the augmentation is initiated.
Phase I: Lessons Learned
Of the perinatal/infant adverse events reported to the Joint Commission on Accreditation of
Healthcare Organizations (JCAHO), 84 percent cited poor or no communication among care
providers as a common factor in those events.28 The lack of a common language increases the
chances of miscommunication among providers when they share information about maternal
and fetal status and expected action. Nurses may have been trained using AWHONN language,
and obstetricians trained using ACOG language. Further investigation has shown that even if a
common language was adopted by both nurses and obstetricians, they continue to train independently.
As a result, communication involving the description of the fetal heart rate tracings is not
consistent among providers and this inconsistency may result in an action different from the
one desired. Highly reliable perinatal teams have adopted a common language (the recently
adopted NICHD language) and train nurses and obstetricians together. During the training,
differences in interpretation are addressed and consensus is obtained regarding the desired action
or response to specific interpretations.
A good example of the lack of consensus around nomenclature is “electronic fetal monitoring,” or
EFM. According to one study, “Complete consensus on EFM nomenclature has not been achieved
within the United States and Canada and is dependent on the descriptive terminology of various
researchers, authors, and equipment manufacturers. Since communication is the essence of quality
and safety, common nomenclature should be established among the members of the same perinatal
healthcare team. This assures that all members comprehend the meaning of pattern implication.”29
In another example, in AWHONN’s Perinatal Nursing textbook (1996), Display 9-4, “Variability
Nomenclature,” lists seven different authors with differing definitions of “variability.” The adoption
by AWHONN and ACOG of the NICHD terminology has now supported one common language
for pattern interpretation — something that has been missing since the first commercially available
electronic fetal monitor was introduced in 1968. Another example of the need for one common
language is the definition of “short- and long-term variability.” Prior to the adoption of the NICHD
terminology in 1997, each individual care provider, physician, or nurse used their own working
definition, developed by researchers such as Parer, Schifrin, Tucker, and Murray.30 The ACOG
Technical Bulletin (Number 207), “Fetal Heart Rate Patterns: Monitoring, Interpretation and
Management,” was in place until May 2005, but did not provide a definition of short- or longterm variability in terms of beats per minute (bpm). Figure 3 illustrates various definitions and
© 2005 Institute for Healthcare Improvement
Institute for Healthcare Improvement Cambridge, Massachusetts
the evolution to the currently accepted NICHD guideline that no longer differentiates between
short- and long-term variability, and instead uses baseline variability.31
Figure 3. Various Definitions of “Variability”
AWHONN Principles and Practices (1993)
Short-term variability:
Long-term variability:
• Absent
• Present
• Decreased/minimal (0–5 bpm)
• Average/within normal limits (6–25 bpm)
• Marked/saltatory (>25 bpm)
Murray et al. (1996)
Short-term variability:
Long-term variability:
• Absent
• Present
• Absent (0–2 bpm)
• Decreased/minimal (3–5 bpm)
• Average/within normal limits (6–25 bpm)
• Marked/saltatory (>25 bpm)
NICHD (1997) [Currently accepted by ACOG and AWHONN]
Baseline variability:
Visually quantified as the amplitude
of peak-to-trough in beats per minute
• Absent (amplitude range undetectable)
• Minimal (amplitude range detectable but 5 bpm or fewer)
• Moderate [normal] (amplitude range 6–25 bpm)
• Marked (amplitude range >25 bpm)
Three elements of the two bundles proved difficult to adopt during Phase I: a policy of no elective
deliveries before 39 weeks of gestational age, definition and management of hyperstimulation, and
estimation and documentation of fetal weight. Teams will continue to test different processes to
ensure reliable compliance with each of the bundle elements. In the case of limiting elective induction
to instances in which gestational age is at least 39 weeks, teams in the Idealized Design project
encountered issues related to physician preferences, workload and coverage issues, and demands
from patients. To address these issues, teams presented guidelines and scientific information supporting
the 39-week limit to the obstetricians practicing at the institutions to reinforce this element of the
bundle. Some organizations set an expectation that there would be no elective inductions before
39 weeks. Once the expectation was set, staff at the hospital were instructed not to schedule elective
inductions if the gestational age was determined to be less than 39 weeks.
Documentation of hyperstimulation proved more elusive, as the definition was more difficult to pin
down. After consultation with expert faculty and internal discussions within their own organizations,
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teams agreed to use one definition for hyperstimulation. The next hurdle was to determine the
clinical response to hyperstimulation. Physicians were reluctant to document estimated fetal weight,
even when it was agreed that this was an estimate and could be listed as a range — LGA (large for
gestational age), AGA (average for gestational age), and SGA (small for gestational age). The concern
for some was the risk associated with estimating incorrectly. Some teams, however, were able to
move ahead successfully by emphasizing that the estimated fetal weight is a range.
The role of leadership, both administrative and clinical, also proved to be essential to success.
Adoption of the elements of the perinatal care bundles, especially the 39-week gestational age limit,
was achieved more readily in organizations where leaders set the expectation that the bundles would
be adopted.
Looking Ahead: Phase II
During Phase II, teams will continue to work on applying IHI’s reliability model to the implementation
of the perinatal care bundles. In addition, Phase II will focus on developing systems to ensure that
a mother’s preferences are known and honored. Teams will also focus on testing their response to
crisis situations by simulating these situations and making changes to improve those processes. The
Idealized Design project also focuses on improving the safety culture of the perinatal unit, which
will be measured using available safety attitude survey tools.32 A Perinatal Trigger Tool will be used
to determine rate of perinatal harm. Another component of the model, the handoff to a receiving
unit, is in development. Additional work in this project will focus on management of second stage
labor and increasing the reliability of the selected processes.
IHI, Ascension Health, and Premier, Inc., remain committed to pursuing this valuable work to
achieve improved outcomes.
© 2005 Institute for Healthcare Improvement
Institute for Healthcare Improvement Cambridge, Massachusetts
References
Improving the Reliability of Health Care. IHI Innovation Series white paper. Boston, MA: Institute
for Healthcare Improvement; 2004. Online information retrieved 14 September 2005. www.ihi.org
1
White AA, Pichert JW, Bledsoe SH, Irwin C, Entman SS. Cause and effect analysis of closed
claims in obstetrics and gynecology. Obstet Gynecol. 2005;105(5 Pt 1):1031-1038.
2
Resar R, Pronovost P, Haraden C, Simmonds T, et al. Using a bundle approach to improve
ventilator care processes and reduce ventilator-associated pneumonia. Joint Commission Journal
on Quality and Patient Safety. 2005;31(5):243-248.
3
Medical Liability Survey Reaffirms More Ob-Gyns Are Quitting Obstetrics. ACOG News
Release, 16 July 2004. Online information accessed 6 December 2005. www.acog.org/from_home/
publications/press_releases/nr07-16-04.cfm
4
Physician Insurers Association of America. Online information retrieved 14 September 2005.
www.thepiaa.org
5
Medical Malpractice: Verdicts, Settlements and Statistical Analysis Updated Edition. Horsham,
PA: Jury Verdict Research; 2005:12.
6
Simpson KR, Knox GE. Common areas of litigation related to care during labor and birth:
Recommendations to promote patient safety and decrease risk exposure. J Perinat Neonat Nurs.
2003;17:110-125.
7
White AA, Pichert JW, Bledsoe SH, Irwin C, Entman SS. Cause and effect analysis of closed
claims in obstetrics and gynecology. Obstet Gynecol. 2005;105(5 Pt 1):1031-1038.
8
For background, see: Berwick D, Kilo C. Idealized design of clinical office practice: An interview
with Donald Berwick and Charles Kilo of the Institute for Healthcare Improvement. Manag Care
Q. 1999 Autumn;7(4):62-69.
9
Also see: Vasquez L, Kancir S, Crede W, Schlosser JE. Using Idealized Design to improve access and
clinical quality. Online information retrieved 13 November 2005. www.scientificsymposium.org/
pdf/2004/Vasquez.pdf
Radel SJ, Norman AM, Notaro JC, Horrigan DR. Redesigning clinical office practices to improve
performance levels in an individual practice association model HMO. J Healthc Qual. 2001 Mar-Apr;
23(2):11-5; quiz 15, 52.
10
Moen RD. A Guide for Idealized Design. Unpublished paper prepared for the Institute for
Healthcare Improvement; 2002. Online information retrieved 13 November 2005. www.ihi.org
11
Testing Changes. Online information retrieved 27 September 2005. www.ihi.org/IHI/Topics/
Improvement/ImprovementMethods/HowToImprove/testingchanges.htm
12
© 2005 Institute for Healthcare Improvement
14
15
Innovation Series: Idealized Design of Perinatal Care
Improving the Reliability of Health Care. IHI Innovation Series white paper. Boston, MA: Institute
for Healthcare Improvement; 2004. Online information retrieved 14 September 2005. www.ihi.org
13
SBAR Technique for Communication: A Situational Briefing Model. Online information
retrieved 14 September 2005. www.ihi.org/IHI/Topics/PatientSafety/SafetyGeneral/Tools/SBAR
TechniqueforCommunicationASituationalBriefingModel.htm
14
Note that these are the three fundamental steps of applying the principles of reliability to health
care. For details, see: Improving the Reliability of Health Care. IHI Innovation Series white paper.
Boston, MA: Institute for Healthcare Improvement; 2004. Online information retrieved 14
September 2005. www.ihi.org
15
Fox M, Kilpatrick S, King T, Parer JT. Fetal heart rate monitoring: Interpretation and collaborative
management. J Midwifery Women’s Health. 2000;45:498-507.
16
AHRQ Patient Safety Indicator for “birth trauma”: “The birth trauma PSI identifies cases of birth
trauma per 1,000 liveborn births in a hospital. This is a patient safety indicator intended to flag
preventable complications of full-term deliveries. The measure excludes preterm deliveries since
birth trauma for these patients may be less preventable than for full-term infants. Risk adjustment
beyond that possible using only administrative data is desirable. While not a definitive measure of
quality, this measure can be used to identify potential opportunities for improvement.” Online
information retrieved 2 December 2005. www.qualityindicators.ahrq.gov/
17
National Healthcare Quality Report 2004, AHRQ Publication No. 05-0013. Online information
retrieved 2 December 2005. www.qualitytools.ahrq.gov/qualityreport/documents/nhqr2004.pdf
18
Agency for Healthcare Research and Quality. Hospital Survey on Patient Safety Culture
(HSOPC). Online information retrieved 2 December 2005. www.ahcpr.gov/qual/hospculture
19
Bundle Up for Safety. Online information retrieved 27 September 2005. www.ihi.org/IHI/
Topics/CriticalCare/IntensiveCare/ImprovementStories/BundleUpforSafety.htm
20
For a guideline that describes best practices in obstetrics, see: Clinical guidelines for the obstetrical
services of the CRICO-insured institutions. Online information retrieved 26 September 2005.
www.rmf.harvard.edu/reference/guidelines/obguide/obguide_03.pdf
Also see: ACOG Practice Bulletin. Clinical Management Guidelines for Obstetrician-Gynecologists.
Number 62, May 2005. Intrapartum fetal heart rate monitoring. Obstet Gynecol. 2005;105(5 Pt 1):
1161-1169.
Resar R, Pronovost P, Haraden C, Simmonds T, et al. Using a bundle approach to improve
ventilator care processes and reduce ventilator-associated pneumonia. Joint Commission Journal on
Quality and Patient Safety. 2005;31(5):243-248.
21
© 2005 Institute for Healthcare Improvement
Institute for Healthcare Improvement Cambridge, Massachusetts
Improving the Reliability of Health Care. IHI Innovation Series white paper. Boston, MA: Institute
for Healthcare Improvement; 2004. Online information retrieved 14 September 2005. www.ihi.org
22
23
ACOG Practice Bulletin, Induction of Labor. Number 10, November 1999.
24
ACOG Practice Bulletin, Intrapartum Fetal Heart Rate Monitoring. Number 70, December 2005.
25
Intrapartum fetal heart rate monitoring. Obstet Gynecol. 2005;105(5 Pt 1):1165.
Low JA, Victory R, Derrick EJ. Predictive value of electronic fetal monitoring for intrapartum
fetal asphyxia with metabolic acidosis. Obstet Gynecol. 1999;93:285-291.
26
27
ACOG, 1999, 2003; AWHONN, 2002.
JCAHO. Preventing infant death during delivery. Sentinel Event Alert #30, 2004. Online information retrieved 21 October 2005. www.jcaho.org/about+us/news+letters/sentinel+event+alert/
sea_30.htm
28
Simpson KR, Creehan PA. AWHONN, Perinatal Nursing. Philadelphia: Lippincott-Raven;
1996:88. 29
30
Ibid.
31
ACOG Practice Bulletin, Intrapartum Fetal Heart Rate Monitoring. Number 70, December 2005.
32
Helmreich RL. On error management: Lessons from aviation. BMJ. 2000;320:781-785.
Additional References
Miller LA. Patient safety and teamwork in perinatal care: Resources for clinicians. Journal of
Perinatal & Neonatal Nursing. 2005;19(1):46-51.
Johnson CE, Handberg E, et al. Improving perinatal and neonatal patient safety: The AHRQ
Patient Safety Indicators. Journal of Perinatal & Neonatal Nursing. 2005;19(1):15-23.
Simpson KR. Failure to rescue: Implications for evaluating quality of care during labor and birth.
Journal of Perinatal & Neonatal Nursing. 2005;19(1):24-34.
Simpson KR, Atterbury J. Trends and issues in labor induction in the United States: Implications
for clinical practice. JOGNN. 2003;32:767-779. 0
© 2005 Institute for Healthcare Improvement
16
White Papers in IHI’s Innovation Series
1
Move Your Dot™: Measuring, Evaluating, and Reducing Hospital Mortality Rates (Part 1)
2
Optimizing Patient Flow: Moving Patients Smoothly Through Acute Care Settings
3
The Breakthrough Series: IHI’s Collaborative Model for Achieving Breakthrough Improvement
4
Improving the Reliability of Health Care
5
Transforming Care at the Bedside
6
Seven Leadership Leverage Points for Organization-Level Improvement in Health Care
7
Going Lean in Health Care
8
Reducing Hospital Mortality Rates (Part 2)
9
Idealized Design of Perinatal Care
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